InnoCare Announces the Approval of Orelabrutinib in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma

BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). Both new drug applications (NDAs) were previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA.

“I would like to thank our entire team at InnoCare for their hard work and contributions,” said Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare. “This approval marks the maturation of InnoCare from a clinical to a commercial stage company.

“The approval of orelabrutinib would not have been possible without the strong support from our partners, physicians, experts and patients who participated in a series of clinical trials,” said Dr. Cui. “Science drives innovation for the benefit of patients. From the initial R&D to patients, orelabrutinib has gone through an extraordinary journey. Treatment with orelabrutinib has demonstrated clear benefit for patients. We remain highly focused on the development of additional high-quality innovative drugs that can address unmet needs.”

Orelabrutinib is a BTK inhibitor developed by InnoCare for the treatment of cancer and autoimmune diseases.

“Compared with other BTK inhibitors, orelabrutinib shows a higher complete response (CR) rate in the treatment of relapsed/refractory (R/R) CLL/SLL patients, and we expect even deeper responses with a longer treatment of patients with orelabrutinib,” said Jianyong Li, M.D., Professor and Director of the Department of Hematology and Director of the Pukou CLL Center at the First Affiliated Hospital of Nanjing Medical University. “We believe that the approval of orelabrutinib will provide a safe and effective new treatment solution for lymphoma patients in China.”

“Data from trials with orelabrutinib have shown sustained efficacy in the treatment of R/R MCL patients,” said Jun Zhu, M.D., Ph.D., Professor and Director of the Department of Internal Medicine and Lymphoma, Peking University Cancer Hospital. “We believe the improved safety profile resulting from high selectivity and the convenience of daily oral administration will help make orelabrutinib a favorable treatment option for patients of B-cell malignancies.”

China represents a large pharmaceutical market. The development of novel drugs requires focused drug discovery efforts, world-class research and development capabilities, state-of-the-art clinical research and significant capital investment.

"Continuous breakthroughs in life science technology are the foundation for the sustainable development of China's healthcare industry in the future,” said Professor Yigong Shi, the co-founder and President of the Science Advisory Board (SAB) of InnoCare. “To promote the research and development of innovative drugs such as orelabrutinib, cutting-edge science is essential, and it is equally critical to integrate collaborations among industry, academia, research institutions and hospitals. By doing so, R&D can keep up with rapidly evolving market needs. At present, although science and technology continue to evolve, we are still far from defeating malignant tumors and autoimmune diseases. I sincerely believe that more innovative companies will emerge in China and make greater contributions to the development of China's healthcare system."

Lymphoma is a malignant tumor that originates from the lymphoid hematopoietic system. Relevant data show that lymphoma is one of the malignant tumors with the fastest growth of incidence rate and one of the top ten malignant tumors with the highest mortality rate in China. Every year, approximately 93,000 people are newly diagnosed with lymphoma, and more than 50,000 people die from it¹. BTK is a key kinase of the B cell receptor (BCR) signaling pathway and an important regulator of B cell proliferation and survival mainly in non-Hodgkin's lymphoma (NHL). BTK inhibitors can block BCR-induced BTK activation and downstream signaling pathways, thereby inhibiting the growth of B-cell tumors and promoting cell apoptosis.

Orelabrutinib is a highly selective and novel BTK inhibitor developed by InnoCare that can avoid off-target-related adverse events with improved safety and efficacy.

About the latest clinical date of orelabrutinib, please refer to: https://cn.innocarepharma.com/en/media/press-release/20201208/

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey, and Boston. 

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¹ Source: https://baijiahao.baidu.com/s?id=1677968646475994848&wfr=spider&for=pc